Luer Connectors

ABSTRACT

Luer connector including a primary Luer male connector, having a secondary female section extending from a top distal part of the primary Luer male connector back towards a proximal part thereof, the primary Luer male connector including a first inner fluid flow channel extending from a proximal end thereof to the secondary female section, the first inner fluid flow channel having a diameter of approximately d1 increasing at a connection point between the first inner fluid flow channel and the secondary female section to form a neck N the secondary female section having an internal diameter of d2 at a top distal part of the primary Luer male connector, where d1 is smaller than d2, the primary Luer male connector being configured to mate with a primary Luer female connector having a secondary male section including a second inner fluid flow channel ex having an internal diameter of approximately d1.

FIELD OF THE INVENTION

Embodiments of the invention are related to Luer connectors configuredto provide essentially undisturbed gas flow and, with possibleprovisions, allow for activation of a gas analyzing device uponachieving conditions allowing essentially undisturbed gas flow andnegligible leak.

BACKGROUND

The Luer Taper is a standardized system of small-scale fluid fittingsused for making leak-free connections between a male-taper fitting andits mating female part on medical and laboratory instruments, includinghypodermic syringe tips and needles or stopcocks and needles. Namedafter the 19th century German medical instrument maker Hermann WulfingLuer, it originated as a 6% taper fitting for glass bottle stoppers. Keyfeatures of Luer Taper connectors are defined in the ISO 594 standards.It is also defined in the DIN and EN standard 1707:1996 and20594-1:1993.

There are two varieties of Luer Taper connections: Luer-Lok andLuer-Slip. Luer-Lok fittings are securely joined by means of a tabbedhub on the female fitting which screws into threads in a sleeve on themale fitting. Luer-Slip fittings simply conform to Luer taper dimensionsand are pressed together and held by friction (they have no threads).Luer components are manufactured either from metal or plastic and areavailable from many companies worldwide.

As mentioned above, the Luer connectors are defined in the ISO 594standard. This standard like many is written by the InternationalOrganization for Standardization (ISO), the worldwide federation ofnational standards bodies (ISO member bodies).

In the 1990s concern grew in the federation regarding the proliferationof medical devices fitted with Luer connectors and the reports ofpatient death or injury arising from misconnections that resulted in theinappropriate delivery of enteral solutions, intrathecal medication orcompressed gases. Concerns regarding the use of Luer connectors withenteral feeding tubes and gas sampling and gas delivery systems wereraised with the European Committee for Standardization (CEN/BT) and theEuropean Commission. In November 1997 the newly created CHeF steeringgroup set up a Forum Task Group (FTG) to consider the problem. The FTGproduced CEN Report CR 13825, which concluded that there is a problemarising from the use of a single connector design for a number ofincompatible applications. In a coronary care unit there are as many as40 connectors on the medical devices used with a single patient.Therefore it is not surprising that misconnections are made. Medicaldevices have for many years followed the established principle of“safety under single fault conditions”. Simply stated this means that asingle fault should not result in an unacceptable risk. This principleis embodied in the requirements of numerous medical device standards.Extending this principle to the application of Luer connectors, i.e.that misconnection should not result in an unacceptable risk to apatient the FTG recommended that Luer connectors should be restricted tomedical devices intended to be connected to the vascular system or ahypodermic syringe. In addition, new designs of small-bore connectorsshould be developed for other applications, and these should benon-interconnectable with Luer connectors and each other.

In reaction to this defined need, during the past few years a new set ofstandards have been developed with the standard ISO/ICE 80369-(1);“Small-bore connectors for liquids and gases in healthcare applications”defining the general requirements for connectors used with fluids in themedical environment, where “Part 2” defines the specific connectors for“breathing systems and driving gases for respiratory use.” This categoryincludes connectors for Capnography, which is the monitoring of theconcentration or partial pressure of CO₂ in respiratory cases.

In Part 2, the requirements for connectors used with breathing systemsand driving gasses are provided including definition and dimensions of arecommended new connector for this purpose. In this document, theconcept, shape and dimensions of the proposed connector fittings aresimilar to the original Luer connectors defined in ISO 594, but itsdimensions are enlarged by some 30%, sufficiently in order that thenewly proposed connector cannot be mated with its original version. Thetapered Luer connector as defined in the original ISO 594 standard wasretained for use with infusion systems only. In fact, a third connectordesign using the same concept and shape, but with smaller dimensions isdefined for a third group of connectors intended for use with enteralapplications. Again, the dimensions have been chosen so thatinter-connectivity among different types of connectors is prevented.

Even in the era when ISO 594 was used to define Luer connectors forbreathing systems, and consequently for Capnography applications, it wasnoted that the defined design for the Luer may not have been optimal forCapnography. Somewhat unique to Capnography, where accurate display ofthe CO2 waveform as created by ever changing inhalation and exhalationstages of breathing is necessary, major attention must be given to howthe sampled breath is transferred from the patient to the measuringdevice. The sampling technique must ensure that the waveform fidelityand shape of the changing CO₂ concentration is kept by using veryconstant laminar flow with an undisturbed wave-front. Such disturbancesare magnified if the gas flow passes via rough tubing, liquid filters,or sections of varying diameter in the tubing, conduits or connectors,abrupt changes in direction and irregularities etc. A measure of meritfor the system ability to transfer the sampled breath from the patientto the measuring sensor of the Capnograph is the system Rise Time(sometimes referred to as the response time). A fast rise time isindicative of a well designed transfer of the sampled breath, while aslow rise time is indicative of a poor transfer of the breath sufferingfrom the disturbing features defined above.

It is noted in Patent application No. US 2008/0284167; Low volumefittings: that the defined shape and dimensions dictated by the ISO 594standard do not lend themselves to providing a fast rise time because ofinevitable changes in the gas flow conduit diameter of the matingconnectors. This is a result of the fact that a preferred diameter forthe internal conduit used for transmitting the sampled gas is 1 mm,especially for a Capnograph that uses low gas sampling flow rates, e.g.50 ml/min. This is further worsened by material choice, since the commonmaterial used for producing these connectors is plastic as it is moreeconomic and appropriate for disposable components With plastic it isdifficult to control tolerances of the 6% tapered cone, and thesedifferences in tolerance dictate differences in the matching and finalposition of the two mated fittings. The problem can be seen in FIG. 1(A, B and C), which shows Luer connectors according to the prior art.Luer connector 10 includes a 6% tapered Luer male connector 12 and Luerfemale connector 14 having an inner a 6% tapered cone. When the matchedfittings (Luer male connector 12 and Luer female connector 14) arecoupled, there still remains a conduit section of length E that maychange because of the inherent tolerances that are inevitable whenproducing mass production, plastic parts, for example, between E min(FIG. 1A), E avg. (FIG. 1B) and E max (FIG. 1C). These E values aredefined in the standard and must be maintained when manufacturing Luerconnector. E max, for that matter, may be defined as the largest (worst)length of conduit that is formed between the Luer male connector andLuer female connector that is still acceptable by the standard.

This drawback is increased considerably with the new pending standard,ISO/CD 80369-1.2, where as mentioned, the new dimensions proposed areeven larger, creating an even larger change in diameters andconsequently distorting further the wave-front and producing an evenslower rise time. Tests performed with Aluminum connectorsrepresentative of the maximum, mean and minimum tolerances (see Table 1hereinbelow) as defined in the new standard have shown up to a 180 msecincrease in rise time, meaning a much slower rise time. Such an increasewould mean that requirements and performance parameters for rise timedefined in Capnograph specifications will become non-compliant.

TABLE 1 Male and Female Aluminum Cones for Large Luer ConnectorSimulators Rise Time Tests: Samples Standard Aluminium Cones Luers RangeParameters max mean Min Mean L_(d.sp.int.), mm  3.5  1.8 ~0.0 2.3Response Time 188_(±19) 92_(±9)  6_(±7) 9_(±9) Tested Samples: TestingConditions: Aluminium Cones: Q_(sampl.) ~50 mL/min.     Male - min & maxdeviations (ID = 5.2). Amb.: 24° C.; 33%; 931 mBar.     Female - min &max deviations. Testing Device: Standard Luer Locks: Capnosat Capnograph(tubing direct to sensor)     Typical Male (ID = 4.0) and Female.(RT_()Back.) ~45 mSec - minimum Rise Time   Symbols for givendimensions:   background.     L_(d.sp.int.) - Male to Female Conesdistance -     internal dimensions.

An attempted solution to this problem is provided in patent applicationNo. US 2008/0284167; Low volume fittings. However, this approach cannotbe used to solve the issue while still remaining compliant to the newstandard: ISO/CD 80369-1.2. For example; see FIGS. 1D and 1E showing aLuer connector 100 as described in patent application: No. US2008/0284167. It is proposed to increase the length of the 6% taperedLuer male connector 102, with an elastomeric material 106 that protrudesaway from Luer male connector 102 by a distance F away from top 108 to adistal surface 110. As a result, when the matched fittings (Luer maleconnector 102 and Luer female connector 104) are coupled, elastomeric(soft) material 106 is squeezed from distance F to distance E and areduced length of large diameter is accomplished and the extendedelastomeric material would prevent the previously inevitable region oflarger diameter conduit and thereby reducing it to a minimum. Such asolution is not permissible with the new standard, since the extendedelastomeric section of the tapered male Luer, and its reducing diameterwith length (6% taper) could easily be pushed into the female connectorof a smaller sized Luer. As explained, three sized Luers with similar 6%tapered cones are expected to be introduced, but their sizes are suchthat when rigid materials as required are used, a larger size Luercannot mate with a smaller defined size. This would not be the case withthe proposed solution in the said application (US 2008/0284167).

To prevent such miss-connection, the new standard requirements dictatethe use of rigid materials as well as an absolute dimension for thediameter of the male and female cone edge i.e. the diameter of thefemale side input edge and male inserting edge noted with the letter “d”for the male side and “D” for the female side. FIG. 2 shows suchsmall-bore connector and its corresponding dimensions (summarized inTable 2 herein below) as appeared in standard ISO/ICE 80369-2.

TABLE 2 Dimension Ref. Designation Minimum Nominal Maximum a: ISO/ICE80369-2 - RESP-125 dimensions of male small-bore connector (dimensionsare in mm unless otherwise indicated). a Angle of taper (degrees) (6%taper nominal) 3.44° 3.44° 3.52° b Thread angle of male lock fitting  50° 50.0°   55° d Diameter at the tip of the male taper 6% 4.851 4.9024.953 e Length of male taper 8.509 8.636 8.763 f Inner diameter at thetip of the male taper 6% 1.0 1.95 2.9 h Major diameter of internalthread of male lock 9.039 9.166 9.293 fitting (diameter at thread root)j Minor diameter of internal thread of male lock 7.747 7.874 8.01fitting (diameter at thread crest) k Thread width of male lock fittingat root 1.06 1.19 1.32 L Length of taper engagement 5.08 5.08 5.70 mWidth between thread flanks at root 1.22 1.350 1.48 n Width betweenthread flanks at crest 1.83 1.96 2.08 o Thread lead, (mm per 360orevolution) 4.95 5.08 5.21 (Right-hand trapezoidal thread is doublestart, 5.1 mm per revolution) p Pitch on internal trapezoidal tread 2.412.54 2.67 q Thread width of male lock fitting at crest 0.46 0.58 0.71 rProjection of nozzle from collar 2.16 2.29 2.41 s Thread length fromcollar end of male lock fitting 7.5 7.6 7.8 u Inner diameter at thefluid lumen (recommended) 2.40 2.55 2.70 w Width of majr projections13.4 13.5 13.8 x Angle of inner lumen taper of the male taper 6% 1.80°2.00° 2.20° y Inner diameter at the end of the male taper 6% 2.58 2.712.84 z Length of inner lumen inside the male taper 6% 9.8 9.9 10.0 (f toy) b: ISO/ICE 80369-2 - RESP-125 dimensions of female small-boreconnector (dimensions are in mm unless otherwise indicated). A Angle offemale taper (6% taper nominal) 3.35° 3.44° 3.44° B Thread angle offemale lock fitting 55.0° 60.0° 60.0° D Diameter at the open of thefemale taper 6% 4.750 4.869 5.004 E Depth of female taper 13.19 13.3113.44 — — — — — H Major diameter of external thread of female lock 8.929.04 9.17 fitting (diameter at thread crest) J Minor diameter ofexternal thread of female lock 7.64 7.77 7.90 fitting (diameter atthread root) K Thread width of female lock fitting at crest 1.12 1.241.37 L Length of taper engagement 5.08 5.08 5.70 M Outside width of lockthread at crest 1.17 1.30 1.42 N Outside width of lock thread at crest1.91 2.03 2.16 O Thread lead, (mm per 360o revolution) (Right-hand 4.975.10 5.23 trapezoidal thread is double start, 5.1 mm per revolution) PPitch of external trapezoidal tread 2.37 2.50 2.63 Q Thread width offemale lock fitting at root 0.38 0.51 0.54 — — — — — S Thread lengthfrom open end of the female taper 6% 2.5 2.7 2.8 U Inner diameter at thefluid lumen (recommended) 2.40 2.55 2.70 W Width of major projections11.4 11.6 11.7 — — — — — — — — — — — — — — — NR—not restricted

Particularly, the diameter at the open end of the female taper 6% isdefined as “D”.

The diameter at the tip of the male taper 6% is defined as “d”.

In addition to the issue of conduits with changing diameters that occurwhen connecting the Luer fittings that comply with the standard, and theslower rise times that they promote, a further issue with these typeconnectors, is that they may incur leaks that will introduce erroneouslylow CO₂ concentrations measurements because of dilution. This is foundmore so with the Luer lock version, i.e. the version where correctmating is realized by screwing the two mating fittings together firmly.In the hospital and emergence environment, the number of tasks requiredand the limited time available together with the state of emergencyoften create a situation where connectors are not mated securely andfirmly. This results, as mentioned in even larger regions of increaseddiameters as well as, in some cases leaks with their negative effect onthe readings. Though the user is required to feel the positive feedbackreceived when the fittings are screwed on correctly, the conditions inthe medical environment often do not lend themselves for the user to besensitive to this feedback.

Hence there is an important need to find an economical means forstructuring and mating two fittings for use with Capnograph monitors andtheir patient interfaces that comply with all the relevant ISOstandards, and that incur only a negligible and minor increase in risetime and will provide a means for permitting gas flow between them onlywhen this condition has been realized without the need for the user tocontrol it.

The foregoing examples of the related art and limitations relatedtherewith are intended to be illustrative and not exclusive. Otherlimitations of the related art will become apparent to those of skill inthe art upon a reading of the specification and a study of the figures.

SUMMARY

The following embodiments and aspects thereof are described andillustrated in conjunction with systems, tools and methods which aremeant to be exemplary and illustrative, not limiting in scope.

There is provided, according to some embodiments, a Luer connector foruse in a respiratory gas sampling and/or delivery tubing systems, theconnector comprising a primary Luer male connector, having a form of atapered cone, comprising a secondary female section extending from a topdistal part of the primary Luer male connector back towards a proximalpart thereof, wherein the primary Luer male connector comprises a firstinner fluid flow channel extending along its length from a proximal endthereof to (and in fluid flow connection with) the secondary femalesection, wherein the first inner fluid flow channel has a diameter ofapproximately d1, wherein the diameter increases at a connection pointbetween the first inner fluid flow channel and the secondary femalesection to form a neck N, wherein the internal diameter of the neck N isbetween d1 and d2, wherein the secondary female section has an internaldiameter of d2 at a top distal part of the primary Luer male connector,wherein d1 is smaller than d2, wherein the primary Luer male connectoris configured to mate with a primary Luer female connector having a formof a tapered cone, wherein at its deepest point, the tapered coneinverts back into a secondary male section and returns into a void ofthe primary Luer female connector, wherein the secondary male sectioncomprises a second inner fluid flow channel extending along the lengththereof and having an internal diameter of approximately d1, whereinwhen the primary Luer male connector and the primary Luer femaleconnector mate with each other, the secondary male section is at leastpartially inserted into the secondary female section.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer female connector havinga form of a tapered cone, wherein at its deepest point, the tapered coneinverts back into a secondary male section and returns into a void ofthe primary Luer female connector, wherein the secondary male sectioncomprises a second inner fluid flow channel extending along the lengththereof and having an internal diameter of approximately d1, wherein theprimary Luer female connector is configured to mate with a primary Luermale connector, having a form of a tapered cone, comprising a secondaryfemale section extending from a top distal part of the primary Luer maleconnector back towards a proximal part thereof, wherein the primary Luermale connector comprises a first inner fluid flow channel extendingalong its length from a proximal end thereof to (and in fluid flowconnection with) the secondary female section, wherein the first innerfluid flow channel has a diameter of approximately d1, wherein thediameter increases at a connection point between the first inner fluidflow channel and the secondary female section to form a neck N, whereinthe internal diameter of the neck N is between d1 and d2, wherein thesecondary female section has an internal diameter of d2 at a top distalpart of the primary Luer male connector, wherein d1 is smaller than d2,wherein when the primary Luer male connector and the primary Luer femaleconnector mate with each other, the secondary male section is at leastpartially inserted into the secondary female section.

According to some embodiments, the secondary male section has a lengthL, which is higher than E max, wherein E max is the maximal distanceformed between the top distal part of primary Luer male connector andthe deepest point of primary Luer female connector, when primary Luermale connector and primary Luer female connector are mated.

According to some embodiments, an inner part of the secondary femalesection comprises at least a portion having a cone shape. An inner partof the secondary female section may be tapered essentially from the neckN to the top distal part of the primary Luer male connector.

According to some embodiments, inner walls of the secondary femalesection are essentially parallel to inner walls of the first and/or thesecond inner fluid flow channels.

According to some embodiments, the secondary female section comprisesthreads on at least a portion of an inner side thereof configured to atleast partially mate with the secondary male section comprising threadson at least a portion of an outer side thereof.

According to some embodiments, the secondary male section comprises oneor more side slits to permit allowance for tolerance.

According to some embodiments, the secondary male section comprises atsealing tip on a top portion thereof.

According to some embodiments, inner walls of the secondary male sectionare essentially parallel to inner walls of the first and/or the secondinner fluid flow channels. According to some embodiments, the secondaryfemale section comprises a first conducting element, wherein the firstconducting element is configured to close a circuit with a secondconducting element positioned on the secondary male section when theprimary Luer female connector and the primary Luer male connector arecorrectly placed with respect to one another. The first conductingelement may be a conducting ring located on an inner circumference ofthe secondary female section and the second conducting element maycomprise electrode strips.

It is noted that a conducting element as referred to herein, may bereplaced with any element (such as, but not limited to, an opticalelement, a magnetic element and an electric element, e.g., inductance,capacitance, resistance element or any combination thereof) that willallow closing of a loop (e.g., circuit) between a first and a secondelements when the primary Luer female connector and the primary Luermale connector are correctly placed with respect to one another. Thus,for example, in case the primary Luer female connector and the primaryLuer male connector are not correctly placed with respect to one anotheror are not matching parts (for example, not configured for gassampling/delivery), the respiratory gas sampling (such as a capnograph)and/or gas delivery system will not be activated and/or an alert will beproduced indicating that the connection between the primary Luer femaleconnector and the primary Luer male connector is not correct/effective.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer male connector, havinga form of a tapered cone, comprising a secondary female sectionextending from a top distal part of the primary Luer male connector backtowards a proximal part thereof, wherein the primary Luer male connectorcomprises a first inner fluid flow channel extending along its lengthfrom a proximal end thereof to (and in fluid flow connection with) thesecondary female section, wherein the first inner fluid flow channel hasa diameter of approximately d1, wherein the diameter increases at aconnection point between the first inner fluid flow channel and thesecondary female section to form a neck N, wherein the internal diameterof the neck N is between d1 and d2, wherein the secondary female sectionhas an internal diameter of d2 at a top distal part of the primary Luermale connector, wherein d1 is smaller than d2, wherein the primary Luermale connector is configured to mate with a primary Luer femaleconnector having a form of a tapered cone, having an opening at itsdeepest point, wherein a spring loaded insert is configured to beinserted through the opening essentially along a central axis of primaryLuer female connector, wherein when the primary Luer male connector andthe primary Luer female connector mate with each other, the springloaded insert is at least partially inserted into the secondary femalesection.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer female connector havinga form of a tapered cone, having an opening at its deepest point,wherein a spring loaded insert is configured to be inserted through theopening essentially along a central axis of primary Luer femaleconnector, wherein the primary Luer female connector is configured tomate with a primary Luer male connector, having a form of a taperedcone, comprising a secondary female section extending from a top distalpart of the primary Luer male connector back towards a proximal partthereof, wherein the primary Luer male connector comprises a first innerfluid flow channel extending along its length from a proximal endthereof to (and in fluid flow connection with) the secondary femalesection, wherein the first inner fluid flow channel has a diameter ofapproximately d1, wherein the diameter increases at a connection pointbetween the first inner fluid flow channel and the secondary femalesection to form a neck N, wherein the internal diameter of the neck N isbetween d1 and d2, wherein the secondary female section has an internaldiameter of d2 at a top distal part of the primary Luer male connector,wherein d1 is smaller than d2, wherein when the primary Luer maleconnector and the primary Luer female connector mate with each other,the spring loaded insert is at least partially inserted into thesecondary female section.

According to some embodiments, the spring loaded insert has a length L,which is higher than E max, wherein E max is the maximal distance formedbetween the top distal part of primary Luer male connector and thedeepest point of primary Luer female connector, when primary Luer maleconnector and primary Luer female connector are mated.

According to some embodiments, inner walls of the secondary femalesection are essentially parallel to inner walls of the first and/or thesecond inner fluid flow channels. According to some embodiments, theinner walls of the secondary female section and the outer walls of thespring loaded insert are conical and adapted to fit each other.

According to some embodiments, the secondary female section comprises afirst conducting element, wherein the first conducting element isconfigured to close a circuit with a second conducting elementpositioned on the spring loaded insert when the primary Luer femaleconnector and the primary Luer male connector are correctly placed withrespect to one another. The first conducting element may be a conductingring located on an inner circumference of the secondary female sectionand the second conducting element may include electrode strips.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer male connector, havinga form of a tapered cone, comprising a secondary female sectionextending from a top distal part of the primary Luer male connector backtowards a proximal part thereof, wherein the primary Luer male connectorcomprises a first inner fluid flow channel extending along its lengthfrom a proximal end thereof to (and in fluid flow connection with) thesecondary female section, wherein the first inner fluid flow channel hasa diameter of approximately d1, wherein the diameter increases at aconnection point between the first inner fluid flow channel and thesecondary female section to form a neck N, wherein the internal diameterof the neck N is between d1 and d2, wherein the secondary female sectionhas an internal diameter of d2 at a top distal part of the primary Luermale connector, wherein d1 is smaller than d2, wherein the primary Luermale connector is configured to mate with a primary Luer femaleconnector having a form of a tapered cone, wherein at its deepest point,the tapered cone inverts back into a secondary male section and returnsinto a void of said primary Luer female connector, wherein the secondarymale section comprises a second inner fluid flow channel extending alongthe length thereof and having an internal diameter of approximately d1,wherein the primary Luer male connector comprises a first electricelement, wherein the first electric element is configured to close acircuit with a second electric element positioned on the primary Luerfemale connector when the primary Luer female connector and the primaryLuer male connector are correctly placed with respect to one another.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer female connector havinga form of a tapered cone, wherein at its deepest point, the tapered coneinverts back into a secondary male section and returns into a void ofthe primary Luer female connector, wherein the secondary male sectioncomprises a second inner fluid flow channel extending along the lengththereof and having an internal diameter of approximately d1, wherein theprimary Luer female connector is configured to mate with a primary Luermale connector, having a form of a tapered cone, comprising a secondaryfemale section extending from a top distal part of the primary Luer maleconnector back towards a proximal part thereof, wherein the primary Luermale connector comprises a first inner fluid flow channel extendingalong its length from a proximal end thereof to (and in fluid flowconnection with) the secondary female section, wherein the first innerfluid flow channel has a diameter of approximately d1, wherein thediameter increases at a connection point between the first inner fluidflow channel and the secondary female section to form a neck N, whereinthe internal diameter of the neck N is between d1 and d2, wherein thesecondary female section has an internal diameter of d2 at a top distalpart of the primary Luer male connector, wherein d1 is smaller than d2,wherein the primary Luer male connector comprises a first electricelement, wherein the first electric element is configured to close acircuit with a second electric element positioned on the primary Luerfemale connector when the primary Luer female connector and the primaryLuer male connector are correctly placed with respect to one another.

According to some embodiments, the secondary female section comprisesthe first electric element, and said secondary male section comprisessaid second electric element. The first and/or second electric elementsmay include a conducting, inductance, capacitance, resistance element orany combination thereof.

According to some embodiments, when the primary Luer male connector andthe primary Luer female connector mate with each other, the secondarymale section is at least partially inserted into the secondary femalesection.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer male connector, havinga form of a tapered cone, comprising a secondary female sectionextending from a top distal part of the primary Luer male connector backtowards a proximal part thereof, wherein the primary Luer male connectorcomprises a first inner fluid flow channel extending along its lengthfrom a proximal end thereof to (and in fluid flow connection with) thesecondary female section, wherein the first inner fluid flow channel hasa diameter of approximately d1, wherein the diameter increases at aconnection point between the first inner fluid flow channel and thesecondary female section to form a neck N, wherein the internal diameterof the neck N is between d1 and d2, wherein the secondary female sectionhas an internal diameter of d2 at a top distal part of the primary Luermale connector, wherein d1 is smaller than d2, wherein the primary Luermale connector is configured to mate with a primary Luer femaleconnector having a form of a tapered cone, having an opening at itsdeepest point, wherein a spring loaded insert is configured to beinserted through the opening essentially along a central axis of primaryLuer female connector, wherein the primary Luer male connector comprisesa first electric element, wherein the first electric element isconfigured to close a circuit with a second electric element positionedon the primary Luer female connector when the primary Luer femaleconnector and the primary Luer male connector are correctly placed withrespect to one another.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer female connector havinga form of a tapered cone, having an opening at its deepest point,wherein a spring loaded insert is configured to be inserted through theopening essentially along a central axis of primary Luer femaleconnector, wherein the primary Luer female connector is configured tomate with a primary Luer male connector, having a form of a taperedcone, comprising a secondary female section extending from a top distalpart of the primary Luer male connector back towards a proximal partthereof, wherein the primary Luer male connector comprises a first innerfluid flow channel extending along its length from a proximal endthereof to (and in fluid flow connection with) the secondary femalesection, wherein the first inner fluid flow channel has a diameter ofapproximately d1, wherein the diameter increases at a connection pointbetween the first inner fluid flow channel and the secondary femalesection to form a neck N, wherein the internal diameter of the neck N isbetween d1 and d2, wherein the secondary female section has an internaldiameter of d2 at a top distal part of the primary Luer male connector,wherein d1 is smaller than d2, wherein the primary Luer male connectorcomprises a first electric element, wherein the first electric elementis configured to close a circuit with a second electric elementpositioned on the primary Luer female connector when the primary Luerfemale connector and the primary Luer male connector are correctlyplaced with respect to one another.

According to some embodiments, the secondary female section comprisesthe first electric element, and the spring loaded insert comprises thesecond electric element. The first and/or second electric elements mayinclude a conducting, inductance, capacitance, resistance element or anycombination thereof.

According to some embodiments, when the primary Luer male connector andthe primary Luer female connector mate with each other, the springloaded insert is at least partially inserted into the secondary femalesection.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer male connector, havinga form of a tapered cone, comprising a secondary female sectionextending from a top distal part of the primary Luer male connector backtowards a proximal part thereof, wherein the primary Luer male connectorcomprises a first inner fluid flow channel extending along its lengthfrom a proximal end thereof to (and in fluid flow connection with) thesecondary female section, wherein the first inner fluid flow channel hasa diameter of approximately d1, wherein the diameter increases at aconnection point between the first inner fluid flow channel and thesecondary female section to form a neck N, wherein the internal diameterof the neck N is between d1 and d2, wherein the secondary female sectionhas an internal diameter of d2 at a top distal part of the primary Luermale connector, wherein d1 is smaller than d2; and a primary Luer femaleconnector having a form of a tapered cone, wherein at its deepest point,the tapered cone inverts back into a secondary male section and returnsinto a void of the primary Luer female connector, wherein the secondarymale section comprises a second inner fluid flow channel extending alongthe length thereof and having an internal diameter of approximately d1,wherein when the primary Luer male connector and the primary Luer femaleconnector mate with each other, the secondary male section is at leastpartially inserted into the secondary female section.

According to some embodiments, the secondary male section has a lengthL, which is higher than E max, wherein E max is the maximal distanceformed between the top distal part of primary Luer male connector andthe deepest point of primary Luer female connector, when primary Luermale connector and primary Luer female connector are mated.

There is provided herein, according to some embodiments, a Luerconnector for use in a respiratory gas sampling and/or delivery tubingsystems, the connector comprising a primary Luer male connector, havinga form of a tapered cone, comprising a secondary female sectionextending from a top distal part of the primary Luer male connector backtowards a proximal part thereof, wherein the primary Luer male connectorcomprises a first inner fluid flow channel extending along its lengthfrom a proximal end thereof to (and in fluid flow connection with) thesecondary female section, wherein said first inner fluid flow channelhas a diameter of approximately d1, wherein the diameter increases at aconnection point between said first inner fluid flow channel and saidsecondary female section to form a neck N, wherein the internal diameterof the neck N is between d1 and d2, wherein the secondary female sectionhas an internal diameter of d2 at a top distal part of the primary Luermale connector, wherein d1 is smaller than d2; and a primary Luer femaleconnector having a form of a tapered cone, having an opening at itsdeepest point, wherein a spring loaded insert is configured to beinserted through the opening essentially along a central axis of primaryLuer female connector, wherein when the primary Luer male connector andthe primary Luer female connector mate with each other, the springloaded insert is at least partially inserted into the secondary femalesection.

According to some embodiments, the spring loaded insert has a length L,which is higher than E max, wherein E max is the maximal distance formedbetween the top distal part of primary Luer male connector and thedeepest point of primary Luer female connector, when primary Luer maleconnector and primary Luer female connector are mated.

According to some embodiments, any one of the connectors disclosedherein may be used in a gas analyzing device, such as, but not limitedto, a capnograph.

There is provided herein, according to some embodiments, a filterhousing for use in a respiratory gas sampling and/or delivery tubingsystems comprising: a primary Luer male connector; wherein the primaryLuer male connector comprises a secondary female section extending froma top distal part of said primary Luer male connector back towards aproximal part thereof, wherein the primary Luer male connector comprisesa first inner fluid flow channel extending along its length from aproximal end thereof; a primary Luer female connector; wherein theprimary Luer female connector at its deepest point, inverts back into asecondary male section, wherein the secondary male section comprises asecond inner fluid flow channel extending along the length thereof; afilter adapted to absorb liquids; and at least one conducting strip.

According to some embodiments, the primary Luer female connector of thefilter housing is adapted to be connected to a primary Luer maleconnector of a patient sampling tube and the primary Luer male connectorof the filter housing is adapted to be connected to a primary Luerfemale connector of a monitor.

According to some embodiments, when the primary Luer female connector ofthe filter housing is connected to the primary Luer male connector of apatient sampling tube the secondary male section of the primary Luerfemale connector of the filter housing is at least partially insertedinto a secondary female section of the primary Luer male connector ofthe patient sampling tube; and when the primary Luer male connector ofthe filter housing is connected to the primary Luer female connector ofthe monitor, a secondary male section of the primary Luer femaleconnector of the monitor is at least partially inserted into thesecondary female section of the primary Luer male connector of thefilter housing.

According to some embodiments activation of the monitor occurs only whenthe entire sampling line is connected. According to some embodimentsconnecting the primary male Luer connector of the filter housing to theprimary Luer female connector of the monitor will not actuate themonitor. According to some embodiments, the monitor is only actuatedwhen the primary Luer female connector of the filter housing iscorrectly connected to the primary Luer male connector of the patientsampling tube and when the primary Luer male connector of the filterhousing is correctly connected to the primary Luer female connector ofthe monitor.

According to some embodiments, the secondary female section of theprimary Luer male connector of the filter housing comprises a firstconducting element, and the secondary male section of the primary Luerfemale connector of the filter housing comprises a second conductingelement.

According to some embodiments, the secondary male section of the primaryLuer female connector of the monitor comprises a third conductingelement. According to some embodiments, the secondary female section ofthe primary Luer male connector of the sampling tube comprises a fourthconducting element.

According to some embodiments, the first and second conducting elementscomprise at least three receiving conductor pads, wherein each receivingconductor pad is separated from its neighboring conducting pad by anon-conducting gap. According to some embodiments first conductingelement and second conducting elements are identical.

According to some embodiments the third conducting element (of themonitor) comprises at least two conducting strips separated by anon-conducting gap.

According to some embodiments the width of the gaps between the at leastthree receiving conductor pads of the first and second conductingelements is less than the width of the at least two conducting strips ofthe third conducting element (of the monitor).

According to some embodiments the fourth conducting elements (of thesampling tube) comprises a conducting ring.

According to some embodiments, only when the primary Luer male connectorof the filter housing is correctly connected to the primary Luer femaleconnector of the monitor, and when the primary Luer Female connector ofthe filter housing is correctly connected to the primary Luer maleconnector of the sampling tube an electric circuit is closed and themonitor is actuated. According to some embodiments, when the primaryLuer male connector of the filter housing is connected to the primaryLuer female connector of the monitor, but primary Luer male connector ofthe patient sampling tube is not connected to the primary Luer femaleconnector of the filter housing, the monitor is not actuated.

According to some embodiments, the filter is a hollow fiber filter.

According to some embodiments, the filter housing further comprises ablocking element adapted to prevent exhaled air from circumventing saidfilter.

According to some embodiments, the filter is molded on the filterhousing to prevent exhaled air from circumventing the filter.

According to some embodiments, the at least one conducting strip isadapted to conduct between the primary female Luer connector of thefilter housing and the primary male connector of the filter housing.

According to some embodiments, the filter housing is configured to beincorporated into a respiratory gas sampling and/or delivery tubingsystems.

There is provided herein, according to some embodiments, filter housingfor use in a respiratory gas sampling and/or delivery tubing systemscomprising:

a first primary Luer male connector; wherein the first primary Luer maleconnector comprises a secondary female section extending from a topdistal part of the first primary Luer male connector back towards aproximal part thereof, wherein the first primary Luer male connectorcomprises a first inner fluid flow channel extending along its lengthfrom a proximal end thereof;

a second primary Luer male connector; wherein the second primary Luermale connector comprises a secondary female section extending from a topdistal part of the second primary Luer male connector back towards aproximal part thereof, wherein the second primary Luer male connectorcomprises a first inner fluid flow channel extending along its lengthfrom a proximal end thereof;

a filter adapted to absorb liquids; and

at least one conducting strip configured to conduct between the firstprimary male Luer connector and the second primary male connector.

According to some embodiments, the first primary Luer male connector ofthe filter housing is adapted to be connected to a primary Luer femaleconnector of a patient sampling tube and the second primary Luer maleconnector of the filter housing is adapted to be connected to a primaryLuer female connector of a monitor.

According to some embodiments, the secondary female section of the firstprimary Luer male connector of the filter housing comprises a firstconducting element, and the secondary female section of the secondprimary Luer male connector of the filter housing comprises a secondconducting element.

According to some embodiments, the first conducting element and thesecond conducting element comprise receiving conductor pads.

According to some embodiments, the secondary male section of the primaryLuer female connector of the monitor further comprises a thirdconducting element. According to some embodiments, the third conductingelement comprises electrode strips.

According to some embodiments, the secondary male section of the primaryLuer female connector of the sampling tube, further comprises a fourthconducting element.

According to some embodiments, the monitor is only actuated when thefirst primary Luer male connector of the filter housing is connected tothe primary Luer female connector of the patient sampling tube and whenthe second primary Luer male connector of the filter housing isconnected to the primary Luer female connector of the monitor.

According to some embodiments, when the first primary Luer maleconnector of the filter housing is connected to the primary Luer femaleconnector of the monitor, but primary Luer female connector of thepatient sampling tube is not connected to the second primary Luer maleconnector of the filter housing, the monitor is not actuated.

BRIEF DESCRIPTION OF THE FIGURES

Exemplary embodiments are illustrated in referenced figures. Dimensionsof components and features shown in the figures are generally chosen forconvenience and clarity of presentation and are not necessarily shown toscale. It is intended that the embodiments and figures disclosed hereinare to be considered illustrative rather than restrictive. The figuresare listed below.

FIGS. 1 A-E show a prior art Luer connector;

FIG. 2 shows a small-bore connector in accordance with standard ISO/ICE80369-2;

FIG. 3A shows a cross section of a Luer connector, according toembodiments of the invention;

FIG. 3B shows a cross section of a Luer connector, according toembodiments of the invention;

FIG. 3C shows a cross section of a Luer connector, according toembodiments of the invention;

FIG. 4 shows a cross section of a Luer connector, according toembodiments of the invention;

FIG. 5 shows a cross section of a Luer connector, according toembodiments of the invention;

FIG. 6 shows a cross section of a Luer connector, according toembodiments of the invention;

FIG. 7 shows a cross section of a filter comprising Luer connectors forassembly into a sampling line, according to embodiments of theinvention;

FIG. 8A schematically illustrates a conducting element according toembodiments of the invention;

FIG. 8B schematically illustrates conducting strips according toembodiments of the invention; and

FIG. 8C schematically illustrates a conducting ring according toembodiments of the invention.

DETAILED DESCRIPTION

There is provided herein, according to some embodiments, a Luerconnector, which includes a primary Luer male connector and a primaryLuer female connector for use in gas tubing system. The Luer connectors,according to embodiments of the invention, may be used anywhere along apatient interface or sampling line. For example, the Luer connector,according to some embodiments, may be positioned at the monitor sidebetween a monitor input connector and a patient interface. In anotherexample, the Luer connector, according to some embodiments, may bepositioned between an airway adaptor or a cannula and a sampling tube.The primary Luer male connector and the primary Luer female connectormay be used interchangeably, for example, the primary Luer maleconnector may be used at the monitor (such as gas capnograph) side andthe primary Luer female connector may be used at the (disposable)sampling line side, or vice versa, the primary Luer female connector maybe used at the monitor (such as gas capnograph) side and the primaryLuer male connector may be used at the (disposable) sampling line side.

According to some embodiment of the invention the proposed solutionsincludes at least one, though preferably two major features, primarily amechanical structure that on one hand complies with the new standardISO/CD 80369-2, but dictates that when the fittings are mated, thechanges and jumps in diameter of the conduits within which the breathsamples flow are reduced to a minimum, and this for a minimum length.Further, dictating minimal leak, even when both the male and femaleconnectors are mated weakly. Secondly, according to some embodiments,the connector provides a simple means for detecting when minimal leak aswell as minimal effect on rise time has been achieved and only then anautomatic detection system activates the monitor sampling capability.

The following four main aspects of Luer connectors are presented assolutions, according to some embodiments, for the problems presentedherein:

Luer Connector—First Aspect:

According to some embodiments, the first feature is accomplished byusing a means comparable to optical systems where mechanical dimensionsof an imaging system with long focal lengths dictate long optical paths.In such systems the optical paths are either folded upon themselves orredirected by mirrors in order to reduce the lengths of the totalsystem. In a similar way, this folding principal is used with male andfemale Luer locks. As discussed, for optimal design with a Capnograph,the 6% tapered conical fitting would have preferably been increased inlength so as to reach the point where the cone intersects the internalorifice of the internal conduit used for transmitting the breath sample.If this were the case, when the male and female Luer would have mated,theoretically there would have been only a negligible change in diameterwhen moving from the male to female connector and hence incurringnegligible effect on the sampled breath rise time.

Such a design, even if it would have been acceptable with its extremelylong connector, is unacceptable by definition in the said new standard,where the final (external) diameter at the end of the tapered connectoris clearly limited to a diameter of 4.58 mm on the male side (defined bythe letter “d”) and 4.87 mm on the female side (defined by the letter“D”) (see Table 1). To overcome this, while still complying with theabove values for “d” and “D”, it is possible to fold over the taperedcone, so that the male connector is extended in length by inverting themale extension into a female section which returns back into the maleextension. The inversion is made when the (external) diameter of themale extension reaches the diameter “d”, the nominal diameter as definedby the standard.

An example of a Luer connector having such inversion can be found inFIG. 3A, which shows a cross section of a Luer connector, according toembodiments of the invention. Luer connector 300 includes primary Luermale connector 302 and primary Luer female connector 304. Primary Luermale connector 302 includes female part which forms secondary femalesection 306 having a cone shape and extending from the top distal part308 of primary Luer male connector 302 back into primary Luer maleconnector 302 towards the proximal part thereof. The primary Luer maleconnector 302 includes a (centralized) first inner fluid flow channel310 extending along its length from a proximal end of primary Luer maleconnector 302 to (and in fluid flow connection with) secondary femalesection 306. First inner flow channel 310 has a diameter of d1. At aconnection point between first inner fluid flow channel 310 and thesecondary female section 306 the internal diameter is increased to forma neck N having surface 360 essentially perpendicular to the inner wallsof first inner fluid flow channel 310, wherein the internal diameter ofthe neck N is between d1 and d2, wherein secondary female section 306has an internal diameter of d2 at top distal part 308 of primary Luermale connector 302, wherein d1 is smaller than d2,

According to another embodiment, not shown, the secondary femalesections shown herein, for example but not limited to, secondary femalesection 306 may not be tapered. For example, secondary female section306 may have an internal diameter of d2 at surface 360 and essentiallythe same internal diameter of d2 at top distal part 308 of primary Luermale connector 302. In other words, the internal walls of the secondaryfemale section (such as secondary female section 306) may be essentiallyparallel to the internal walls of first or second inner fluid flowchannels (such as first inner fluid flow channel 310).

Comparably, on the mating connector, primary Luer female connector 304,which is primarily female in shape, at its deepest point 312, thetapered cone 314 inverts back into a secondary male section 316, whichhas a cone shape and returns back into the void space of primary Luerfemale connector 304. The second inner fluid flow channel 318 extendingalong secondary male section 316 has a diameter of d1.

The diameter at the open end of primary Luer female connector (taper 6%)304 is defined as “D”.

The (external) diameter at the tip of the primary Luer male connector(taper 6%) 302 defined as “d”.

In this manner, the two connectors (primary Luer male connector 302 andprimary Luer female connector 304) still mate well, retain thedimensions “d” and “D” required by the standard but become more compact,and end with small diameters (d1) far less than “d” and “D”, so thatwhen gases flow from one to the other, minor changes in diameter areincurred and consequently reduce the effect on the rise time. In thismanner, inadvertent insertion of a larger sized male Luer into a smallersized female Luer is prevented as required by the new standard.

It is noted that for simplicity, the original part of the male andfemale Luer are called the primary male and female sections, while theinverted sections are referred to as the secondary male and femalesections.

According to some embodiments, the secondary male and female sections(such as secondary male section 316 and secondary female section 306)have tapered angles whose tolerances are on the lower side of thetapered angle of the primary male and female sections (such as primaryLuer male connector 302 and primary Luer female connector 304). This isin order that the two fittings do not close first on the shorter andsmaller secondary male and female sections, but mate primarily with theprimary male and female cones. It is also possible to produce thesecondary male Luer section from a softer material than that used tomake the secondary female section, where in this manner the secondarymale section can be made of the same taper and its tolerances as theprimary Luer. This addition of a soft material will still comply withthe standard, since soft materials are disqualified from the design onlyfor those regions where a dimension has been specified, and hence wherethe soft material will permit distortion and non-compliance of therequired dimension.

According to some embodiments, an outer section of Luer connector 300further includes screwing capability of one connector to its matingconnector. Specifically, Luer male connector 302 includes threads 320 onan outer part thereof and primary Luer female connector 302 includesthreads 322 on an outer part thereof.

It is noted that the Luer connectors, according to embodiment of theinvention, can either be of normal Luer or of slip Luer, i.e. withexternal thread or without external thread, respectively.

According to some embodiments, when primary Luer male connector 302 andprimary Luer female 304 mate with each other, secondary male section 316is at least partially inserted to secondary female section 306.

According to some embodiments, secondary male section 316 has a lengthL, which is higher than E max, wherein E max is the maximal distancebetween top distal part 308 of primary Luer male connector 302 anddeepest point 312 of primary Luer female connector 304, when primaryLuer male connector 302 and primary Luer female connector 304 are matedand wherein the tolerances of their cones are at their limits (see forexample FIG. 1C) and hence mating occurs early in the mating process.

The second feature, according to some embodiment, is used for detectingthat the parts as designed above only actuates the monitor when minimalleaks and negligible changes in diameter have been realized. For thispurpose, several methods can be used, for example, a method which isbased on detecting changes to an electric circuit by either closing thecircuit, changing its inductance or capacitance or the resistance inpart of it, etc. Alternatively, a method which is based on detectingoptical or magnetic changes can also be applied. For example, if on themonitor side, a primary female Luer lock is used, (two) electrode strips(for example 324 and 328) can line either the primary female opening(not shown) or secondary male section 316 to a point where when matingprimary Luer male connector 302 is correctly placed it should reach thispoint of electrodes strips 324 and 328. On the mating primary Luer maleconnector 302, on the end thereof or internally at the end of secondaryfemale section 306, a conducting ring 326 is placed. According to someembodiments, conducting ring 326 is positioned on the innercircumference of secondary female section 306. When the connectors arecorrectly and sufficiently in place, conducting ring 326 will close acircuit ending with electrode strips 324 and 328. Electrode strips 324and 328 are, in turn connected to a circuit that can detect if there isconductance between the two or not, where on detection a signal isproduced which consequently actuates the pump used to provide thesampling.

According to some embodiments, the term correctly placed as refers toherein, defines a mating between a primary Luer female connector and aprimary Luer male connector where there is no significant deteriorationor slowing of rise time, and where negligible leaking of sampled gas canoccur.

Inductance or capacitance can also be used, or any other method whichcan change electronic characteristics of a circuit when two dielectricor conducting materials and surfaces are positioned one relevant to theother. The overlap of the two material surfaces may result from thecorrect mating of the connectors, or from reaching a distance betweenthem which will change the electric characteristics proportionally tothe level of mating between the two connectors. These changes can bedetected by the monitor, actuating the monitor sampling system only whencorrect mating is achieved.

In a further embodiment, the conducting ring could vary in resistance,which when measured, can be used as an indicator for a given type orclass monitor or type and class patient interface as ended with therelevant connector.

Another example of such inversion can be found in FIG. 3B, which shows across section of a Luer connector, according to embodiments of theinvention. Luer connector 300′ resembles Luer connector 300 of FIG. 3Aexcluding the structure of the secondary male section. Luer connector300′ includes primary Luer male connector 302′ and primary Luer femaleconnector 304′. Primary Luer male connector 302′ includes female partwhich forms secondary female section 306′ having a cone shape andextending from the top distal part 308′ of primary Luer male connector302′ back into primary Luer male connector 302′ towards the proximalpart thereof. The primary Luer male connector 302′ includes a(centralized) first inner fluid flow channel 310′ extending along itslength from a proximal end of primary Luer male connector 302′ to (andin fluid flow connection with) secondary female section 306′. Firstinner channel 310′ has a diameter of d1.

At a connection point between first inner fluid flow channel 310′ andthe secondary female section 306′ the internal diameter is increased toform a neck N having surface 360′ essentially perpendicular to the innerwalls of first inner fluid flow channel 310′, wherein the internaldiameter of the neck N is between d1 and d2, wherein secondary femalesection 306′ has an internal diameter of d2 at top distal part 308 ofprimary Luer male connector 302′, wherein d1 is smaller than d2, Viceversa, on the mating connector, primary Luer female connector 304′,which is primarily female in shape, at its deepest point 312′, thetapered cone 314′ inverts back into a secondary male section 316′, whichreturns back into the void space of primary Luer female connector 304′.The second inner fluid flow channel 318′ extending along secondary malesection 316′ has a diameter of d1. Secondary male section 316′ has acone shape only at a tip 330 thereof (the part that is most remote fromdeepest point 312′ of Luer female connector 304′. Cone shape tip 330 hastwo (but can be one or more) side slits 340 and 342 to permit allowancefor tolerance. A top view of tip 330 is shown in the circle.

The diameter at the open end of primary Luer female connector (taper 6%)304′ is defined as “D”.

The (external) diameter at the tip of the primary Luer male connector(taper 6%) 302′ defined as “d”.

In this manner, the two connectors (primary Luer male connector 302′ andprimary Luer female connector 304′) still mate well, retain thedimensions “d” and “D” required by the standard but become more compact,and end with small diameters (d1) far less than “d” and “D”, so thatwhen gases flow from one to the other, minor changes in diameter areincurred and consequently reducing the effect on the rise time. In thismanner inadvertent insertion of a larger sized male Luer into a smallersized female Luer is prevented as required by the new standard.

It is noted that for simplicity, the original part of the male andfemale Luer are called the primary male and female sections, while theinverted sections are referred to as the secondary male and femalesections.

According to some preferred embodiments, tip 330 of secondary malesection 316′ and secondary female section 306′ have tapered angles whosetolerances are on the lower side of the tapered angle of the primarymale and female sections (such as primary Luer male connector 302′ andprimary Luer female connector 304′). This is in order that the twofittings do not close first on the shorter and smaller secondary maleand female sections, but mate primarily with the primary male and femalecones. This effect is also assisted by the incomplete shape of tip 330(slits) as discussed above.

According to some embodiments, an outer section of Luer connector 300′further includes screwing capability of one connector to its matingconnector. Specifically, Luer male connector 302′ includes threads 320′on an outer part thereof and primary Luer female connector 302′ includesthreads 322′ on an outer part thereof.

According to some embodiments, when primary Luer male connector 302′ andprimary Luer female 304′ mate with each other, secondary male section316′ is at least partially inserted to secondary female section 306′.

According to some embodiments, secondary male section 316′ has a lengthL, which is higher than E max, wherein E max is the maximal distancebetween top distal part 308′ of primary Luer male connector 302′ anddeepest point 312′ of primary Luer female connector 304′, when primaryLuer male connector 302′ and primary Luer female connector 304′ aremated and wherein the tolerances of their cones are at their limits (seefor example FIG. 1C) and hence mating occurs early in the matingprocess.

The second feature, according to some embodiments, is used for detectingthat the parts as designed above only actuate the monitor when minimalleaks and negligible changes in diameter have been realized. For thispurpose, several methods can be used, for example, a method which isbased on detecting changes to an electric circuit by either closing thecircuit, changing its inductance or capacitance or the resistance inpart of it, etc. Alternatively, a method which is based on detectingoptical or magnetic changes can also be applied. For example, if on themonitor side, a primary female Luer lock is used, two electrodes strip(for example 324′ and 328′) can line either the primary female opening(not shown) or tip 330 of secondary male section 316′ (to a point wherewhen mating primary Luer female connector 302′ is correctly placed itshould reach this point of electrodes strips 324′ and 328′. On themating primary Luer male connector 302′, on the end thereof orinternally at the end of secondary female section 306′, a conductingring 326′ is placed. According to some embodiments, conducting ring 326′is positioned on all the inner circumference of secondary female section306′. When the connectors are correctly and sufficiently in place,conducting ring 326′ will close a circuit ending with electrode strips324′ and 328′. Electrode strips 324′ and 328′ are in turn connected to acircuit that can detect if there is conductance between the two or not,where on detection a signal is produced which consequently actuates thepump used to provide the sampling.

According to some embodiments, the term correctly placed defines amating where there is no significant deterioration or slowing of risetime, and where negligible leaking of sampled gas can occur.

Inductance or capacitance can also be used, or any other method whichcan change electronic characteristics of a circuit when two dielectricor conducting materials and surfaces are positioned one relevant to theother. The overlap of the two material surfaces may result from thecorrect mating of the connectors, or from reaching a distance betweenthem which will change the electric characteristics proportionally tothe level of mating between the two connectors. These changes can bedetected by the monitor, actuating the monitor sampling system only whencorrect mating is achieved.

In a further embodiment, the conducting ring could vary in resistance,which when measured, can be used as an indicator for a given type orclass monitor or type and class patient interface as ended with therelevant connector.

Another example of such inversion can be found in FIG. 3C, which shows across section of a Luer connector, according to embodiments of theinvention. Luer connector 300″ resembles Luer connector 300 of FIG. 3Aexcluding the structure of the secondary male section. Luer connector300″ includes primary Luer male connector 302″ and primary Luer femaleconnector 304″. Primary Luer male connector 302″ includes female partwhich forms secondary female section 306″ having a cone shape andextending from the top distal part 308″ of primary Luer male connector302′ back into primary Luer male connector 302″ towards the proximalpart thereof. The primary Luer male connector 302″ includes a(centralized) first inner fluid flow channel 310″ extending along itslength from a proximal end of primary Luer male connector 302″ to (andin fluid flow connection with) secondary female section 306″. Firstinner channel 310″ has a diameter of d1. At a connection point betweenfirst inner fluid flow channel 310″ and the secondary female section306″ the internal diameter is increased to form a neck N having surface360″ essentially perpendicular to the inner walls of first inner fluidflow channel 310″, wherein the internal diameter of the neck N isbetween d1 and d2, wherein secondary female section 306″ has an internaldiameter of d2 at top distal part 308″ of primary Luer male connector302″, wherein d1 is smaller than d2, Vice versa, on the matingconnector, primary Luer female connector 304″, which is primarily femalein shape, at its deepest point 312″, the tapered cone 314″ inverts backinto a secondary male section 316″, which returns back into the voidspace of primary Luer female connector 304″. The second inner fluid flowchannel 318′ extending along secondary male section 316″ has a diameterof d1. Secondary male section 316″ has a sealing tip 370 at the partthat is most remote from deepest point 312′ of Luer female connector304′. Sealing tip 370 is made of a material softer than that ofsecondary male section 316″ (it may be made of, for example, an 0 ring,a PVC ball or any other material which can be used for sealing). Theinner walls of secondary male section 316″ may (as shown) or may not betapered (cone shape).

The diameter at the open end of primary Luer female connector (taper 6%)304″ is defined as “D”.

The (external) diameter at the tip of the primary Luer male connector(taper 6%) 302″ defined as “d”.

In this manner, the two connectors (primary Luer male connector 302″ andprimary Luer female connector 304″) still mate well, retain thedimensions “d” and “D” required by the standard but become more compact,and end with small diameters (d1) far less than “d” and “D”, so thatwhen gases flow from one to the other, minor changes in diameter areincurred and consequently reduce the effect on the rise time. In thismanner inadvertent insertion of a larger sized male Luer into a smallersized female Luer is prevented as required by the new standard.

It is noted that for simplicity, the original part of the male andfemale Luer are called the primary male and female sections, while theinverted sections are referred to as the secondary male and femalesections.

According to some embodiments, an outer section of Luer connector 300″further includes screwing capability of one connector to its matingconnector. Specifically, Luer male connector 302″ includes threads 320″on an outer part thereof and primary Luer female connector 302″ includesthreads 322″ on an outer part thereof.

According to some embodiments, when primary Luer male connector 302″ andprimary Luer female 304″ mate with each other, secondary male section316″ is at least partially inserted to secondary female section 306″.

According to some embodiments, secondary male section 316″ has a lengthL, which is higher than E max, wherein E max is the maximal distancebetween top distal part 308″ of primary Luer male connector 302″ anddeepest point 312″ of primary Luer female connector 304″, when primaryLuer male connector 302″ and primary Luer female connector 304″ aremated and wherein the tolerances of their cones are at their limits (seefor example FIG. 1C) and hence mating occurs early in the matingprocess.

According to some embodiments (not shown), similar to those described inFIG. 3A, a second feature, according to some embodiment, may be used fordetecting that the parts as designed above only actuate the monitor whenminimal leaks and negligible changes in diameter have been realized.

Another example of such inversion can be found in FIG. 4, which shows across section of a Luer connector, according to embodiments of theinvention. Luer connector 400 includes primary Luer male connector 402and primary Luer female connector 404. Primary Luer male connector 402includes female section which forms secondary female section 406 havinga cone shape and extending from the top distal part 408 of primary Luermale connector 402 back into primary Luer male connector 402 towards theproximal part thereof. The primary Luer male connector 402 includes a(centralized) first inner fluid flow channel 410 extending along itslength from a proximal end of primary Luer male connector 402 to (and influid flow connection with) secondary female section 406. First innerchannel 410 has a diameter of d1. Secondary female section 406 istapered such that it starts having a diameter of d1 and tapers to aninternal diameter of d2 at top distal part 408 of primary Luer maleconnector 402, such that d1 is smaller than d2.

Comparably, on the mating connector, primary Luer female connector 404,which is primarily female in shape, at its deepest point 412, thetapered cone 414 inverts back into a secondary male section 416, whichhas a cone shape and returns back into the void space of primary Luerfemale connector 404. The second inner fluid flow channel 418 extendingalong secondary male section 416 has a diameter of d1.

The diameter at the open end of primary Luer female connector (taper 6%)404 is defined as “D”.

The (external) diameter at the tip of the primary Luer male connector(taper 6%) 402 defined as “d”.

In this manner, the two connectors (primary Luer male connector 402 andprimary Luer female connector 404) still mate well, retain thedimensions “d” and “D” required by the standard but become more compact,and end with small diameters (d1) far less than “d” and “D”, so thatwhen gases flow from one to the other, minor changes in diameter areincurred and consequently reduce the effect on the rise time. In thismanner inadvertent insertion of a larger sized male Luer into a smallersized female Luer is prevented as required by the new standard.

It is noted that for simplicity, the original part of the male andfemale Luer are called the primary male and female sections, while theinverted sections are referred to as the secondary male and femalesections.

According to some preferred embodiments, the secondary male and femalesections (such as secondary male section 416 and secondary femalesection 406) have tapered angles whose tolerances are on the lower sideof the tapered angle of the primary male and female sections (such asprimary Luer male connector 402 and primary Luer female connector 404).This is in order that the two fittings do not close first on the shorterand smaller secondary male and female sections, but mate primarily withthe primary male and female cones. It is also possible to produce thesecondary male Luer section from a softer material than that used tomake the secondary female section, where in this manner the secondarymale section can be made of the same taper and its tolerances as theprimary Luer.

According to some embodiments, an outer section of Luer connector 400further includes screwing capability of one connector to its matingconnector. Specifically, Luer male connector 402 includes threads 420 onan outer part thereof and primary Luer female connector 404 includesthreads 422 on an outer part thereof.

According to some embodiments (not shown), similar to those described inFIG. 3A, a second feature, according to some embodiment, may be used fordetecting that the parts as designed above only actuate the monitor whenminimal leaks and negligible changes in diameter have been realized.

Luer Connector—Second Aspect:

According to some embodiments, this aspect includes at least one, thoughpreferably two major features. Primarily a mechanical design that on onehand complies with the new standard ISO/CD 80369-2, but dictates thatwhen the fittings are mated, the changes and discontinuities in diameterof the conduits within which the breath samples flow are reduced to aminimum, and this for a minimum length. This design further dictatesminimal leak, even when both the male and female connectors are matedweakly. Secondly, the design provides a simple means for detecting whenminimal leak as well as minimal effect on rise time has been achievedand only then an automatic detection system activates the monitorsampling capability.

This design also benefits from a further advantage yet mentioned: Adesign that can solve a further problem that will be caused by adheringto the new standard. As mentioned, the new standard dictates a largerdimensioned connector for mating between male and female parts. Thus notonly will connectors joined to patient interfaces, consumables and looseparts be required to change but so will their counterparts on devices(such as capnographs). The relevant devices, already in the field, onthe market etc. and designed with existing Luer connectors havepredefined layouts and space allocations on the devices panel as well asspace requirements within the device. The new connectors will dictatemore space, both in radius and in depth. Since the devices when designeddid not take these new dimensions into account, it is possible thatpre-existing devices may require large changes to accommodate the newLuer connectors.

Hence with this aspect, according to some embodiments of the invention,the outer section of the Luer connector typically used to date forproviding a screwing capability of one connector to its mating connector(see FIG. 4, threads 420 on the outer part of Luer male connector 402and threads 422 on the outer part of primary Luer female connector 404)is removed, and this screwing capability and structure is transferred tothe central axis (see FIG. 5 herein below).

According to some embodiments, this first feature with this aspect isaccomplished by using a means comparable to optical systems wheremechanical dimensions of an imaging system with long focal lengthsdictate long optical paths. In such systems the optical paths are eitherfolded upon themselves or redirected by mirrors in order to reduce thelengths of the total system. In a similar way, this folding principal isused with male and female Luer locks. As discussed above, for optimaldesign with a Capnograph, the 6% tapered conical fitting would havepreferably been increased in length so as to reach the point where thecone intersects the internal orifice of the internal conduit used fortransmitting the breath sample. If this were the case, when the male andfemale Luer would have mated, theoretically there would have been only anegligible change in diameter when moving from the male to femaleconnector and hence incurring negligible effect on the sampled breathrise time.

Such a design, even if it would have been acceptable with its extremelylong connector, is unacceptable by definition in the said new standard,where the final (external) diameter at the end of the tapered connectoris clearly limited to a diameter of 4.58 mm on the male side (defined bythe letter “d”) and 4.87 mm on the female side (defined by the letter“D”) (see Table 1). To overcome this, while still complying with theabove values for “d” and “D”, it is possible to fold over the taperedcone, so that the male connector is extended in length by inverting themale extension into a female section which returns back into the maleextension. The inversion is made when the (external) diameter of themale extension reaches the diameter “d”, the nominal diameter as definedby the standard. This male (hollow) extension does not continue with a6% tapered conical shaped hollow cone, but has constant internaldiameter and includes an appropriate thread structure matching a similarthread structure to be placed on the mating connector.

Comparably, on the mating connector which is primarily female in shape,at its deepest point, the tapered cone inverts back into a constantdiameter extension which includes an appropriate thread structurematching the similar thread structure placed on the mating connector(see FIG. 5).

For simplicity, the original part of the male and female Luer will becalled the primary male and female sections, while the inverted sectionsare referred to as the secondary male thread and female thread sections.

Hence, the two connectors are screwed firmly together in order to matethe two opposing 6% tapered cones using the smaller diameter threadedsecondary sections.

In this manner, the two connectors still mate well, retain thedimensions “d” and “D”, but become more compact, and end with smalldiameters far less than “d” and “D”, so that when gases flow from one tothe other, minor changes in diameter are incurred consequently reducingthe effect on the rise time. In this manner, inadvertent insertion of alarger sized male Luer into a smaller sized female Luer is prevented asrequired by the new standard. Further, the entire connector dimensionsare reduced sufficiently that despite the use of larger tapered Luers,the overall size is reduced by removing the external thread section,consequently permitting a one to one fitting with existing designeddevice panels.

An example of a Luer connector according to the Second Aspect can befound in FIG. 5, which shows a cross section of a Luer connector,according to embodiments of the invention. Luer connector 500 includesprimary Luer male connector 502 and primary Luer female connector 504.Primary Luer male connector 502 includes female section which formssecondary female section 506 having threads 530 and extending from thetop distal part 508 of primary Luer male connector 502 back into primaryLuer male connector 502 towards the proximal part thereof. The primaryLuer male connector 502 includes a (centralized) first inner fluid flowchannel 510 extending along its length from a proximal end of primaryLuer male connector 502 to (and in fluid flow connection with) secondaryfemale section 506. First inner channel 510 has a diameter of d1.Secondary female section 506 has a diameter of d1 at a proximal end 511thereof (where it connects with to first inner channel 510) and aninternal diameter of d2 at top distal part 508 of primary Luer maleconnector 502, such that d1 is smaller than d2.

Comparably, on the mating connector, primary Luer female connector 504,which is primarily female in shape, at its deepest point 512, thetapered cone 514 inverts back into a secondary male section 516, whichhas threads 540 and returns back into the void space of primary Luerfemale connector 504. The second inner fluid flow channel 518 extendingalong secondary male section 516 has a diameter of d1. Threads 530 ofsecondary female section 506 and threads 540 of secondary male section516 are configured to mate. As noted herein above the Luer connectors,according to embodiment of the invention, can either be of normal Lueror of slip Luer, i.e. with external thread or without external thread,respectively. However, with Luer connectors such as Luer connector 500there is no need an external thread, which may be an advantage.

The diameter at the open end of primary Luer female connector (taper 6%)504 is defined as “D”.

The diameter at the tip of the primary Luer male connector (taper 6%)502 defined as “d”.

In this manner, the two connectors (primary Luer male connector 502 andprimary Luer female connector 504) still mate well, retain thedimensions “d” and “D” required by the standard but become more compact,and end with small diameters (d1) far less than “d” and “D”, so thatwhen gases flow from one to the other, minor changes in diameter areincurred consequently reducing the effect on the rise time. In thismanner, inadvertent insertion of a larger sized male Luer into a smallersized female Luer is prevented as required by the new standard.

It is noted that for simplicity, the original part of the male andfemale Luer are called the primary male and female sections, while theinverted sections are referred to as the secondary male and femalesections.

The second feature, according to some embodiment, is used for detectingthat the parts as designed above only actuate the monitor when minimalleaks and negligible changes in diameter have been realized. For thispurpose, several methods can be used, for example, a method which isbased on detecting changes to an electric circuit by either closing thecircuit, changing its inductance or capacitance or the resistance inpart of it, etc. Alternatively, a method which is based on detectingoptical or magnetic changes can also be applied. For example, if on themonitor side, a primary female Luer lock is used, (two) electrodes strip(for example 524 and 528) can line either the primary female opening(not shown) or secondary male section 516 (to a point where when matingprimary Luer male connector 502 is correctly placed it should reach thispoint of electrodes strips 524 and 528. On the mating primary Luer maleconnector 502, on the end thereof or internally at the end of secondaryfemale section 506, a conducting ring 526 is placed. According to someembodiments, conducting ring 526 is positioned on the innercircumference of secondary female section 506. When the connectors arecorrectly and sufficiently in place, conducting ring 526 will close acircuit ending with electrode strips 524 and 528. Electrode strips 524and 528 are in turn connected to a circuit that can detect if there isconductance between the two or not, where on detection a signal isproduced which consequently actuates the pump used to provide thesampling.

According to some embodiments, the term correctly placed defines amating where there is no significant deterioration or slowing of risetime, and where negligible leaking of sampled gas can occur.

Inductance or capacitance can also be used, or any other method whichcan change electronic characteristics of a circuit when two dielectricor conducting materials and surfaces are positioned one relevant to theother, where the overlap of two material surfaces result from thecorrect mating of the connectors, or where a distance between them willchange the electric characteristics that are proportional to the levelof mating between the two connectors. These changes can be detected bythe monitor, actuating the monitor sampling system only when correctmating is achieved.

In a further embodiment, the conducting ring could vary in resistance,when measured, can be used as an indicator for a given type or classmonitor or type and class patient interface as ended with the relevantconnector.

Luer Connector—Third Aspect:

According to some embodiments, this aspect includes at least one, thoughpreferably two major features, Primarily a mechanical design that on onehand complies with the new standard ISO/CD 80369-1.2, but dictates thatwhen the fittings are mated, the changes and jumps in diameter of theconduits within which the breath samples flow are reduced to a minimum,and this for a minimum length. This design further dictates minimalleak, even when both the male and female connectors are mated weakly.Secondly, the design provides a simple means for detecting when minimalleak as well as minimal effect on rise time has been achieved and onlythen a an automatic detection system activates the monitor samplingcapability.

According to some embodiments, the first feature is accomplished byusing a means comparable to optical systems where mechanical dimensionsof an imaging system with long focal lengths dictate long optical paths.In such systems the optical paths are either folded upon themselves orredirected by mirrors in order to reduce the lengths of the totalsystem. In a similar way, this folding principal is used with male andfemale Luer locks. As discussed above, for optimal design with aCapnograph, the 6% tapered conical fitting would have preferably beenincreased in length so as to reach the point where the cone intersectsthe internal orifice of the internal conduit used for transmitting thebreath sample. If this were the case, when the male and female Luerwould have mated, theoretically there would have been only a negligiblechange in diameter when moving from the male to female connector andhence incurring negligible effect on the sampled breath rise time.

Such a design, even if it would have been acceptable with its extremelylong connector, is unacceptable by definition in the said new standard,where the final diameter at the end of the tapered connector is clearlylimited to a diameter of 4.58 mm on the male side (defined by the letter“d”) and 4.87 mm on the female side (defined by the letter “D”) (seeTable 1). To overcome this, while still complying with the above valuesfor “d” and “D”, it is possible to fold over the tapered cone, so thatthe male connector is extended in length by inverting the male extensioninto a female section which returns back into the male extension. Theinversion is made when the diameter of the male extension reaches thediameter “d”, the nominal diameter as defined by the standard. Thisfemale type extension can be either conical or straight in shape whosedepth is limited with respect to the end of the primary male section. Itends internally with a female abutting section (see for example, FIG. 6herein below).

On the other hand, on the mating connector which is primarily female inshape, at its deepest point, and along its central axis, a separate,spring loaded tubular insert inverts back into the void space of thefemale section (see for example, FIG. 6 herein below). The spring loadedtubular sections have a diameter and shape that fits the femaleextension of its opposing connector. When the two connectors are mated,the extension of the spring loaded tube is so designed as to abut withthe abutting section of the opposing connector at an early stage of themating process, where any further pushing or screwing of the twoconnectors together will create force on the spring, pushing the springloaded tubular extension backwards, through at the same time retainingthe tube abutted to the female abutting section.

For simplicity, the original part of the male and female Luer will becalled the primary male and female sections, while the inverted sectionsare referred to as the spring loaded tubular section and the secondaryfemale sections.

In this manner, the two connectors will mate well, retaining thedimensions “d” and “D”, but become more compact, and end with negligiblediameters far less than “d” and “D”, so that when gases flow from one tothe other, minor changes in diameter if at all are incurred consequentlyreducing the effect on the rise time. In this manner, inadvertentinsertion of a larger sized male Luer into a smaller sized female Lueris prevented as required by the new standard.

According to some embodiments, the spring loaded section can be shapedas tubular or conical. Further, according to some embodiments, theabutting regions may be rounded for better matching. According to someembodiments, the depth of the protruding spring loaded tubing, shouldtake into consideration the tolerances of 6% tapered cone Luers in orderto accommodate for the possible final positions when mated.

An Example of a Luer connector according to the Third Aspect can befound in FIG. 6, which shows a cross section of a Luer connector,according to embodiments of the invention. Luer connector 600 includesprimary Luer male connector 602 and primary Luer female connector 604.Primary Luer male connector 602 includes female section which formssecondary female section 606 extending from the top distal part 608 ofprimary Luer male connector 602 back into primary Luer male connector602 towards the proximal part thereof. Primary Luer male connector 602includes a (centralized) first inner fluid flow channel 610 extendingalong its length from a proximal end of primary Luer male connector 602to (and in fluid flow connection with) secondary female section 606.First inner channel 610 has a diameter of d1. Secondary female section606 has a diameter of d1 at a proximal end 611 thereof (where itconnects with to first inner channel 610) and a diameter of d3 at topdistal part 608 of primary Luer male connector 602, such that d1 issmaller than d3.

Comparably, on the mating connector, primary Luer female connector 604,which is primarily female in shape, at its deepest point 612, thetapered cone 614 has an opening 613 having a diameter of d3. Throughopening 613 and along a central axis of primary Luer female connector604, a separate, spring loaded tubular insert 650 inverts back into thevoid space of tapered cone 614 of primary Luer female connector 604.Spring loaded tubular (section) insert 650 has a diameter and shape thatfits secondary female section 606 of primary Luer male connector 602. Itis noted that the spring loaded insert may be tubular as shown (springloaded tubular insert 650) but may also have other shapes or forms. Forexample it could be conical or partially conical and configure toconnect with a matching conical or partially conical secondary femalesection. When the two connectors (primary Luer male connector 602 andprimary Luer female connector 604) are mated, spring loaded tubularinsert 650 is designed such that its top distal section is inserted intosecondary female section 606 of the opposing connector (primary Luermale connector 602) at an early stage of the mating process, where anyfurther pushing or screwing of the two connectors together will createforce on spring 670, pushing spring loaded tubular insert 650 backwards.Though at the same time, retaining spring loaded tubular insert 650abutted to the female abutting section 660. The inner diameter of springloaded tubular insert 650 is d1, same as the diameter of first innerchannel 610 of primary Luer male connector 602, such that when springloaded tubular insert 650 is designed to abut with abutting section 660of primary Luer male connector 602 a continuous inner channel having adiameter of d1 is formed. It is noted that, according to someembodiments, the spring loaded tubular insert may also be conical andconfigured to fit a conical secondary female section when mated.

The diameter at the open end of primary Luer female connector (taper 6%)604 is defined as “D”.

The diameter at the tip of the primary Luer male connector (taper 6%)602 defined as “d”.

In this manner, the two connectors (primary Luer male connector 602 andprimary Luer female connector 604) still mate well, retain thedimensions “d” and “D” required by the standard but become more compact,and end with small diameters (d1) far less than “d” and “D”, so thatwhen gases flow from one to the other, minor changes in diameter areincurred consequently reducing the effect on the rise time. In thismanner, inadvertent insertion of a larger sized male Luer into a smallersized female Luer is prevented as required by the new standard.

The second feature, according to some embodiment, is used for detectingthat the parts as designed above only actuate the monitor when minimalleaks and negligible changes in diameter have been realized. For thispurpose, several methods can be used, for example, a method which isbased on detecting changes to an electric circuit by either closing thecircuit, changing its inductance or capacitance or the resistance inpart of it, etc. Alternatively, a method which is based on detectingoptical or magnetic changes can also be applied. For example, if on themonitor side, a primary female Luer lock is used, (two) electrodes strip(for example 624 and 628) can line either the primary female opening(not shown) or on the tip of spring loaded tubular insert 650 (to apoint where when mating primary Luer male connector 602 is correctlyplaced it should reach this point of electrodes strips 624 and 628. Onthe mating primary Luer male connector 602, on the end thereof orinternally at the end of secondary female section 606, a conducting ring626 is placed (on abutting section 660). When the connectors arecorrectly and sufficiently in place, conducting ring 626 will close acircuit ending with electrode strips 624 and 328. Electrode strips 324and 328 are in turn connected to a circuit that can detect if there isconductance between the two or not, where on detection a signal isproduced which consequently actuates the pump used to provide thesampling.

According to some embodiments, the term correctly placed defines amating where there is no significant deterioration or slowing of risetime, and where negligible leaking of sampled gas can occur.

According to some embodiments, electrodes 680 may be used on either sideof the moving spring loaded tubular insert 650. Electrodes 680 areconfigured to be connected before any mating connector enters, and to beseparated, to break the circuit when the spring loaded parted is pushedinwards as would happen when a correct mating has been connected.

Inductance or capacitance can also be used, or any other method whichcan change electronic characteristics of a circuit when two dielectricor conducting materials and surfaces are positioned one relevant to theother, where the overlap of two material surfaces result from thecorrect mating of the connectors, or where a distance between them willchange the electric characteristics that is proportional to the level ofmating between the two connectors. These changes can be detected by themonitor, actuating the monitor sampling system only when correct matingis achieved.

In a further embodiment, the conducting ring could vary in resistance,when measured, can be used as an indicator for a given type or classmonitor or type and class patient interface as ended with the relevantconnector.

Luer Connector—Fourth Aspect:

According to some embodiments, this aspect includes at least one, thoughpreferably three major features. Primarily a mechanical design that onone hand complies with the new standard ISO/CD 80369-2, but dictatesthat when the fittings are mated, the changes and discontinuities indiameter of the conduits within which the breath samples flow arereduced to a minimum, and this for a minimum length. This design furtherdictates minimal leak, even when both the male and female connectors aremated weakly. Secondly, the design provides a simple means for detectingwhen minimal leak as well as minimal effect on rise time has beenachieved and only then an automatic detection system activates themonitor sampling capability. Thirdly, the design enables coupling anappropriate filtering system designed to absorb liquids and hinderingthem from reaching sensitive monitors such as e.g., a capnograph, byusing Luer connectors as those essentially described above. Hence, thedesign enables modulating the sampling line by for example exchanging apatient cannula while maintaining the filter without jeopardizingsafety. This since only when an appropriate filter is connected to theappropriate connectors on the patient cannula and on the monitor, theautomatic detection system activates the monitor sampling capability

An Example of a modulatory sampling line according to the Fourth Aspectof the invention can be found in FIG. 7.

According to some embodiments of the invention, disclosed is a samplingline comprising a sampling tube encompassing a filter housing, whereinsaid filter housing comprises a primary Luer male connector adapted toconnect to the primary Luer female connector of a monitor.

According to some embodiments of the invention, disclosed is amodulatory sampling line 800, comprising a filter housing 1000,connecting between a primary Luer male connector 702 of a patientsampling tube 810, and a primary Luer female connector 704 which is apart of a monitor such as for example a capnograph. According to someembodiments of the invention, the connections are made by usingsequential Luer connectors.

Filter housing 1000 comprises a primary Luer female connector 1004 onone end thereof (for example on the patient side) and a primary Luermale connector 1002 on the other end thereof (for example on the monitorside), a filter 1100 adapted to absorb liquids and at least oneconducting strip, such as conducting strips 1400 and 1500.

According to some embodiments, filter 1100 can be any filter adapted toabsorb liquids such as, but not limited to, a hollow fiber filter.

According to some embodiments filter housing 1000 further comprises ablocking agent 1200 adapted to prevent exhaled air from circumventingfilter 1000. Alternatively, filter 1100 can be molded on filter housing1000 so as to prevent exhaled air from circumventing said filter.

According to some embodiments, primary Luer male connector 1002 includesa female part which forms a secondary female section 1006 extending froma top distal part 1008 of primary Luer male connector 1002 back intoprimary Luer male connector 1002 towards the proximal part thereof.Primary Luer male connector 1002 includes a (centralized) first innerfluid flow channel 1010 extending along its length from a proximal endof primary Luer male connector 1002 to (and in fluid flow connectionwith) secondary female section 1006 as essentially described above.

According to some embodiments, primary Luer male connectors 702 includesfemale part which forms a secondary female section 706 extending from atop distal part 708 of primary Luer male connector 702 back into primaryLuer male connector 702 towards the proximal part thereof. Primary Luermale connector 702 includes a (centralized) first inner fluid flowchannel 710 extending along its length from a proximal end of primaryLuer male connector 702 to (and in fluid flow connection with) secondaryfemale section 706 as essentially described above.

Primary Luer female connector 1004, which is primarily female in shape,at its deepest point 1012, inverts back into a secondary male section1016, which returns back into the void space of primary Luer femaleconnector 1004, wherein said secondary male section 1016 comprises asecond inner fluid flow channel 1018 extending along the length thereofas essentially described above.

Primary Luer female connector 704, which is primarily female in shape,at its deepest point 712, inverts back into a secondary male section716, which returns back into the void space of primary Luer femaleconnector 704 as essentially described above.

According to some embodiments, primary Luer female connector 1004 isadapted to be connected to primary Luer male connector 702 of patientsampling tube 810, as essentially described above. According to someembodiments, primary Luer male connector 1002 is adapted to be connectedto primary Luer female connector 704 of a monitor such as for example acapnograph, as essentially described above.

According to some embodiments, sampling line 800 is configured to allowactivation of the monitoring device only when its components arecorrectly assembled and an electric circuit is closed. According to someembodiments, the monitor, such as a capnograph, is only actuated whenthe entire sampling line 800 is correctly assembled. Specifically, themonitor is only actuated when primary Luer female connector 1004 iscorrectly and/or sufficiently connected to primary Luer male connector702 and when primary Luer male connector 1002 is correctly and/orsufficiently connected to primary Luer female connector 704. Accordingto some embodiments connecting primary male Luer connector 1002 toprimary Luer female connector 704 will not actuate the monitor. This isin order to avoid that the monitor will work without being connected toa patient, thereby causing a reduced lifespan of the monitor.

According to some embodiments, secondary female section 1006 of primaryLuer male connector 1002 comprises a first conducting element such asfor example conducting element 1026 schematically illustrated in FIG. 8a, and secondary male section 1016 of primary Luer female connector 1004comprises a second conducting element, such as for example conductingelement 1026 schematically illustrated in FIG. 8 a. According to someembodiments, the first and second conducting element each comprise atleast three receiving conductor pads, such as conducting pads 1025,1027, 1029 wherein each receiving conductor pad is separated from itsneighboring conducting pad by a non-conducting gap such as gap 1030.According to some embodiments, first conducting element and secondconducting element may be identical. According to some embodiments,first conducting element and second conducting element may be different.

According to some embodiments, secondary male section 716 of the primaryLuer female connector 704 of the monitor comprises a third conductingelement, such as conducting strips 724 and 728 schematically illustratedin FIG. 8 b. According to some embodiments conducting strips 724 and 728are separated by a non-conducting gap 730.

According to some embodiments the width L1 of the gaps such as gap 1030(FIG. 8 a) is less than the width L2 of each of conducting strips 724and 728 (FIG. 8 b).

According to some embodiments, secondary female section 706 of primaryLuer male connector 702 comprises a fourth conducting element such asconducting ring 726 schematically illustrated in FIG. 8 c.

According to some embodiments, when only primary Luer male connector1002 is correctly connected to primary Luer Female connector 704 of themonitor an electric circuit is not closed and the monitor is notactuated.

According to some embodiments, only when primary Luer male connector1002 is correctly connected to primary Luer female connector 704 of themonitor, and when primary Luer female connector 1004 is correctlyconnected to primary Luer male connector 702 of sampling tube 810 anelectric circuit is closed and the monitor is actuated.

According to some embodiments, the term correctly placed as referred toherein, defines a mating between a primary Luer female connector and aprimary Luer male connector where there is no significant deteriorationor slowing of rise time, and where negligible leaking of sampled gas canoccur.

It is to be understood that, several methods can be used for the purposeof activating the monitor only upon proper assembly of the entiresampling line (such as sampling line 800). For example, a method whichis based on detecting changes to an electric circuit by either closingthe circuit, changing its inductance or capacitance or the resistance ina part of it, etc. According to some embodiments, conducting strips 1400and 1500 are adapted to electrically connect between primary female Luerconnector 1004 and primary male connector 1002.

According to some embodiments, conducting strips 1400 and 1500 areadapted to conduct between primary female Luer connector 1004 andprimary male connector 1002.

Thus, according to some embodiments, once sampling line 800 is correctlyassembled, an electric circuit is closed between: electrodes strips 724and 728 on primary Luer female connector 704 of a monitor, firstconducting element such as conducting element 1026 on primary maleconnector 1002, conducting strips 1400 and 1500, second conductingelement such as conducting element 1026 on primary female Luer connector1004 and conducting ring 726 on primary male connector 702 of patientsampling tube 810.

It is to be understood by the skilled in the art, that inductance orcapacitance can also be used, or any other method which can changeelectronic characteristics of a circuit when two dielectric orconducting materials and surfaces are positioned one relevant to theother. According to some embodiments, the overlap of two materialsurfaces may result from the correct mating of the connectors, or fromreaching a distance between them which will change the electriccharacteristics proportionally to the level of mating between the twoconnectors. These changes can be detected by the monitor, actuating themonitor sampling system only when correct mating is achieved.

In a further embodiment, the conducting rings could vary in resistance,which when measured, can be used as an indicator for a given type orclass monitor or type and class patient interface as ended with therelevant connector.

It is to be understood by the skilled in the art that modulatorysampling line 800 facilitates to exchange some parts of modulatorysampling line 800, such as for example patient sampling tube 810, whilefacilitating reuse of other parts of modulatory sampling line 800 suchas for example filter housing 1000.

It is noted that for simplicity, the original part of the male andfemale Luer are called the primary male and female sections, while theinverted sections are referred to as the secondary male and femalesections.

Likewise, it is to be understood, that the primary Luer male connectorand the primary Luer female connector may be used interchangeably, forexample, the primary Luer male connector may be used at the monitor sideand the primary Luer female connector may be used at the filter side, orvice versa, the primary Luer female connector may be used at the monitorside and the primary Luer male connector may be used at the filter side.Similarly, the primary Luer male connector may be used at the patientsampling tube side and the primary Luer female connector may be used atthe filter side, or vice versa, the primary Luer female connector may beused at the patient sampling tube side and the primary Luer maleconnector may be used at the filter side.

According to some embodiments, the same primary Luer connectors may beused on the monitor side and on the sample tube side. For example aprimary Luer female connector may be used on both the monitor side andon the sample tube side whereas a primary Luer male connector may beused on both sides of the filter. For example a primary Luer maleconnector may be used on both the monitor side and on the sample tubeside whereas a primary Luer female connector may be used on both sidesof the filter. This embodiment avoids connecting a sampling tube (nothaving a filter) directly to a monitor without encompassing a filterthereby potentially harming the monitor.

It is noted that the Luer connectors, according to embodiment of theinvention, can either be of normal Luer or of slip Luer, i.e. withexternal thread or without external thread, respectively.

Furthermore, an ordinary skilled in the art will understand that all theLuer connectors used in this aspect of the invention can be any of theLuer connectors disclosed herein and described in FIGS. 3-6.

In addition to the exemplary aspects and embodiments described above,further aspects and embodiments will become apparent by reference to thefigures and by study of the following detailed description.

1. A primary Luer female connector, comprising: a tapered cone, whereinthe tapered cone inverts back into a secondary male section and returnsinto a void of said primary Luer female connector, said secondary malesection comprising: a first inner fluid flow channel extending along thelength thereof, and a conducting material configured to close a circuitwith an electric element positioned on a secondary female section of aprimary Luer male connector, when said primary Luer female connector andsaid primary Luer male connector at least partially mate with oneanother.
 2. The connector of claim 1, wherein when said primary Luermale connector and said primary Luer female connector mate with eachother, said secondary male section is at least partially inserted intosaid secondary female section and a second inner fluid flow channel inthe primary male Luer connector extends along its length from a proximalend thereof to and in fluid flow connection with said secondary femalesection.
 3. The connector of claim 2, wherein each of said first andsecond inner fluid flow channels have an internal diameter ofapproximately d1, wherein said secondary female section has an internaldiameter d2 at a distal part of said primary Luer male connector,wherein the diameter of said second inner fluid flow channel increasesat a connection point between said second inner fluid flow channel andsaid secondary female section to form a neck N, wherein the internaldiameter of said neck N is between d1 and d2, and wherein d1 is smallerthan d2.
 4. The connector of claim 2, wherein said secondary malesection has a length L, which is higher than E max, wherein E max is themaximal distance formed between a distal part of primary Luer maleconnector and a base of primary Luer female connector, when primary Luermale connector and primary Luer female connector are mated.
 5. Theconnector of claim 1, wherein said conducting material covers the entiresecondary male section.
 6. The connector of claim 1, wherein saidsecondary male section is made of said conducting material.
 7. Theconnector of claim 1, wherein said secondary male section comprisesthreads on at least a portion of an outer side thereof.
 8. The connectorof claim 1, wherein said secondary male section comprises one or moreside slits to permit allowance for tolerance.
 9. The connector of claim1, wherein said secondary male section comprises a sealing tip.
 10. Theconnector of claim 1, wherein inner walls of said secondary male sectionare essentially parallel to inner walls of said first inner fluid flowchannel.
 11. The connector of claim 1, further comprising a firstoptical element positioned on the secondary male section, wherein saidfirst optical element is arranged to connect with a second opticalelement positioned on said primary Luer male connector when said primaryLuer female connector and said primary Luer male connector at leastpartially mate with one another.
 12. The connector of claim 11, whereinsaid first optical element comprises at least one light source.
 13. Theconnector of claim 1, further comprising one or more componentspositioned on the secondary male section configured to actuate a patientmonitor when said primary Luer female connector is connected to saidprimary Luer male connector.
 14. The connector of claim 1, furthercomprising one or more components positioned on the secondary malesection configured to provide data indicative of a type of patientinterface.
 15. A primary Luer female connector adapted to mate with acomplementary primary Luer male connector, said primary Luer femaleconnector comprising: a member having a frustoconical void formedtherein, the frustoconical void defined by a tapered conical wall and agenerally planar floor, a secondary male section extending from thefloor out into the frustoconical void, said secondary male sectionhaving formed therein a fluid flow channel extending along a lengththereof, and comprising a conducting material configured to close acircuit with an electric element positioned on said primary Luer maleconnector when said primary Luer female connector and said primary Luermale connector at least partially mate with one another.